MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 27mm watchman laa closure device was implanted.Warfarin and 81 mg of aspirin was prescribed for 6 weeks after implant.The 81 mg of aspirin was held for a few days post op due to the concern for gastrointestinal bleeding but was then restarted.At the 6-week follow-up appointment, warfarin was stopped and 75mg of plavix was started.The patient was to remain on plavix for a year; however, it was stopped (b)(6) 2019 due to weakness and dyspnea.The 81 mg of aspirin continued.Approximately 23 months post implant, the patient was admitted for other reasons and a device related thrombus was noted.The patient was admitted after undergoing computed tomography pulmonary embolus (ctpe) for dyspnea which identified the left atrial thrombus attached to the device.The patient underwent a transthoracic echocardiogram (tte) that was not definitive in terms of evaluating the left atrium for identification of the reported thrombus.The patient was initiated on heparin and later transitioned to apixaban 5 mg twice daily.The decision was made not to load patient with 10 mg for 5 days given age and risk factors for bleeding.The patient was able to undergo a transesophageal echocardiogram (tee) for better visualization of the left atrium.The tee revealed a non-mobile device-related thrombus measuring 2.4 x 1.4 cm.The patient will continue apixaban with further follow-up in the cardiology clinic.The patient will have repeat transesophageal echocardiogram in 6 weeks for evaluation of the left atrial thrombus.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12283046
• Report Number: 2134265-2021-10027
• Device Sequence Number: 17047112
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023763202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other